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Dexmedetomidine Versus Magnesium Sulfate in Ultrasound Guided Bilateral Bi-level Erector Spinae Plane Block in Corrective Scoliosis Surgery

Primary Purpose

Anesthesia , Analgesia

Status
Active
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Magnesium sulfate
Narcotic Analgesics
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia , Analgesia

Eligibility Criteria

14 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients who will be scheduled for indicated open corrective scoliosis surgery in the prone position. physical status American Society of Anesthesiologists (ASA) I or II. Exclusion Criteria: patients refuse to participate. . -ASA physical status >II. patients who have contraindications to regional analgesic procedures as infection at injection site patients who have major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological). allergy to the study drugs a known history of recent opioid use obesity (body mass index (BMI) > 35 kg/m2) those who underwent revision surgery coagulopathy drug or alcohol abuse epilepsy, or a psychiatric illness that would interfere with the perception and assessment of pain.

Sites / Locations

  • Ain Shams University hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

General anethesia +Dexmedetomidine plus Bupivacaine for Erector spinae plane block

General anethesia +Magnesium sulfate plus Bupivacaine for Erector spinae plane block

general anesthesia+conventional postoperative narcotic analgesia

Arm Description

Outcomes

Primary Outcome Measures

First time to analgesic requirement
All patients will receive an IV PCA system (Accufuser M8P, 100 mL: Woo Young Meditech Co, S. Korea). PCA was prepared with 100 mL of isotonic saline containing 50 mg morphine, and the selected system was adjusted to infuse a 5 mL bolus dose with a lockout interval of 15 minutes while the basal flow rate was switched off.

Secondary Outcome Measures

Full Information

First Posted
January 1, 2023
Last Updated
September 30, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05671081
Brief Title
Dexmedetomidine Versus Magnesium Sulfate in Ultrasound Guided Bilateral Bi-level Erector Spinae Plane Block in Corrective Scoliosis Surgery
Official Title
Dexmedetomidine Versus Magnesium Sulfate in Ultrasound Guided Bilateral Bi-level Erector Spinae Plane Block in Corrective Scoliosis Surgery: A Randomized Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 5, 2023 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Posterior spinal fusion for scoliosis surgery may lead to severe postoperative pain which requires significant opioid use for adequate perioperative analgesia. This postoperative pain extends the time of recovery, and thus, safe, and efficient methods for perioperative analgesia are crucial and advantageous for early recovery and ambulation. Traditional opioid-based analgesia techniques are characterized by well-known complications such as vomiting, nausea, sedation, and pruritus. Although regional anesthesia is an essential part of multimodal analgesia, available options are limited. Recently, an ultrasound (US)-guided erector spinae plane block (ESPB) method that anesthetizes ventral and dorsal rami of spinal nerves was introduced for the treatment of both postoperative and neuropathic pain. Due to the arousing interest of several physicians, ESPB application is reported to be effective in the breast, weight loss, and lumbosacral spine surgeries as it reduces the need for analgesic drugs. The main advantages of the ESPB are technical simplicity, minimal risk for the spinal cord, and fewer complications. The ESP block is a fascial plane block that aims to inject a local anesthetic mixture within a plane beneath the erector spinae muscle at the transverse process of the vertebra. ESP block can provide effective postoperative analgesia for upper abdominal surgery when performed at the thoracic vertebra 7-8 level. ESP block acts probably by diffusion of local anaesthetic into the paravertebral space. The advantages of ESP block are its ease of performance and safety. Owing to its superficial location, away from vessels and nerves, the complications associated with paravertebral block can be avoided. The effect of magnesium was first recognized for the treatment of arrhythmia and preeclampsia, and its effect on anaesthesia and analgesia has recently been recognized. Magnesium sulphate has also been used as an adjunct to anaesthesia in recent years. It is also an effective analgesic agent for perioperative pain. Research has also reported that the intraoperative use of magnesium is characterized by a reduced use of anesthetics and muscle relaxants. Furthermore, opioid use, postoperative nausea and vomiting, hypertension, and shivering have met a decreased trend with the use of magnesium sulphate. Magnesium sulfate (MgSO4) may be helpful as an analgesic adjuvant in regional anesthesia because it improves and prolongs the analgesic effect of local anesthetics; moreover, MgSO4 alone modulates the transmission of nociceptive stimuli and pain perception by blocking the N-methyl-D-aspartate (NMDA) receptor. Dexmedetomidine (DE) is a potent α2 adrenoreceptor agonist and it is highly selective for α2 adrenoreceptor seven times more than clonidine. Many studies documented a prolonged duration and rapid onset of sensory block with the perineural injection of DE. Dexmedetomidine has been introduced as an adjuvant to local anaesthetics in both neuroaxial and peripheral nerve blocks. perineural dexmedetomidine has shown to prolong the duration of postoperative analgesia in addition to reducing the opioid consumption.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia , Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
General anethesia +Dexmedetomidine plus Bupivacaine for Erector spinae plane block
Arm Type
Active Comparator
Arm Title
General anethesia +Magnesium sulfate plus Bupivacaine for Erector spinae plane block
Arm Type
Active Comparator
Arm Title
general anesthesia+conventional postoperative narcotic analgesia
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
patients will receive combined general anesthesia and bilateral bilevel at T5 &T10 Erector spinae plane block with 20mL of bupivacaine 0.125 %. plus 0.5 μg/kgof Dexmedetomidine for each injection
Intervention Type
Drug
Intervention Name(s)
Magnesium sulfate
Intervention Description
patients will receive combined general anesthesia and bilateral bilevel at T5 &T10 Erector spinae plane block with 20mL of bupivacaine 0.125 %. plus 2 mg/kg Magnesium sulfate for each injection
Intervention Type
Drug
Intervention Name(s)
Narcotic Analgesics
Intervention Description
patients will receive general anesthesia and conventional intraoperative and postoperative analgesia
Primary Outcome Measure Information:
Title
First time to analgesic requirement
Description
All patients will receive an IV PCA system (Accufuser M8P, 100 mL: Woo Young Meditech Co, S. Korea). PCA was prepared with 100 mL of isotonic saline containing 50 mg morphine, and the selected system was adjusted to infuse a 5 mL bolus dose with a lockout interval of 15 minutes while the basal flow rate was switched off.
Time Frame
1st 48 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients who will be scheduled for indicated open corrective scoliosis surgery in the prone position. physical status American Society of Anesthesiologists (ASA) I or II. Exclusion Criteria: patients refuse to participate. . -ASA physical status >II. patients who have contraindications to regional analgesic procedures as infection at injection site patients who have major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological). allergy to the study drugs a known history of recent opioid use obesity (body mass index (BMI) > 35 kg/m2) those who underwent revision surgery coagulopathy drug or alcohol abuse epilepsy, or a psychiatric illness that would interfere with the perception and assessment of pain.
Facility Information:
Facility Name
Ain Shams University hospitals
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

Dexmedetomidine Versus Magnesium Sulfate in Ultrasound Guided Bilateral Bi-level Erector Spinae Plane Block in Corrective Scoliosis Surgery

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